NCT00345124

Brief Summary

The aim of the study is to test the following hypotheses:

  • that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
  • if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

3 years

First QC Date

June 24, 2006

Last Update Submit

June 27, 2011

Conditions

Essential Hypertension and Healthy Controls

Keywords

urinary aquaporin-2ENaCfractional sodium excretionHigh/low sodium diet

Outcome Measures

Primary Outcomes (4)

  • u-AQP-2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • fractional sodium excretion

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • p-vasopressin

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • p-aldosterone

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary Outcomes (6)

  • u-p-AQP-2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • u-ENaC(alfa,beta,gamma)

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • CH2O

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • u-cAMP

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • uPGE2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • +1 more secondary outcomes

Interventions

high sodium dietBEHAVIORAL

250-350 mmol

Also known as: For four days
Low Sodium DietBEHAVIORAL

25-35 mmol

Also known as: For four days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian men and women
  • Age 18-65 years
  • Arterial hypertension
  • Body mass index between 18.5 and 30 kg/m2

You may not qualify if:

  • Secondary hypertension
  • Isolated systolic hypertension
  • History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
  • Malignant disease
  • Prior apoplexy
  • alcohol or drug abuse
  • Drug use except antihypertensives and oral contraceptives
  • Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (\> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
  • Abnormal screening of the urine regarding: Blood, albumine and glucose.
  • abnormal electrocardiogram
  • Blood donation within one month of the first examination day
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

Related Publications (1)

  • Graffe CC, Bech JN, Lauridsen TG, Vase H, Pedersen EB. Abnormal increase in urinary aquaporin-2 excretion in response to hypertonic saline in essential hypertension. BMC Nephrol. 2012 Mar 27;13:15. doi: 10.1186/1471-2369-13-15.

    PMID: 22452789DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Erling B. Pedersen, Professor

    Department of Medical Research, Holstebro Hospital, Denmark

    STUDY CHAIR

  • Carolina C. Graffe, MD

    Department of Medical Research, Holstebro Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2006

First Posted

June 27, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

DK(1)